Biovest International, Inc. (OTCQB: BVTI), a majority-owned subsidiary
of Accentia Biopharmaceuticals, Inc. (OTCQB: ABPI), today announced that
the U.S. National Cancer Institute (NCI) presented long-term (median
10-year follow-up) outcomes at the 2012 American Society of Clinical
Oncology Annual Meeting (ASCO 2012) from a Phase II BiovaxID® lymphoma
vaccine clinical trial. The results (detailed in Abstract #2528),
reported in a poster presented by the NCI, demonstrated that vaccination
following rituximab combination chemotherapy induced nearly universal
T-cell immune responses, the elevation of which strongly correlated with
overall survival and time-to-next treatment benefits in patients with
mantle cell lymphoma (MCL), a highly aggressive form of B-cell
non-Hodgkin's lymphoma.
Wyndham H. Wilson, M.D., Ph.D., Chief of the Lymphoma Therapeutics
Section at NCI and the principal investigator of the MCL study, stated
in an article published in Genetic Engineering & Biotechnology News (GEN),
"We found that among MCL patients treated with a hybridoma-based
idiotype vaccine, patients who had T-cells that produced GM-CSF when
exposed to tumor antigen had a significantly longer survival and delayed
time to next treatment compared to patients who did not have GM-CSF
producing T-cells. Interestingly, studies have shown that GM-CSF
producing T-cells are important for promoting autoimmunity, which is
what we hope an antitumor vaccine will do. In the latter case, the
autoimmunity is against a tumor antigen and not a normal cell."
Additionally, Sattva S. Neelapu, M.D., Associate Professor at the
Department of Lymphoma/Myeloma, Division of Cancer Medicine, The
University of Texas MD Anderson Cancer Center (Houston, TX), a
co-investigator of this Phase II study and an investigator on the Phase
III (BV301) BiovaxID clinical trial in follicular lymphoma, commented
that, "These results complement the body of data supporting the safety
and efficacy of BiovaxID."
The studylow-risk' MIPI
patients and substantially exceeding reported historic overall survival
rates for 'high-risk' and 'intermediate-risk' MIPI patients. Furthermore, the study demonstrates a highly
statistically-significant association between overall survival and
specific vaccine-induced anti-tumor GM-CSF cytokine (T-cell) responses.
Overall Survival Benefit in MCL: Patients with a high degree of
this T-cell response to vaccination experienced an estimated survival of
approximately 75% at 10-years, compared to a survival of approximately
25% in the group of patients with a low degree of T-cell GM-CSF
responses. Overall, patients with the T-cell response
experienced an approximately three-fold improvement in their probability
of survival compared with those did not achieve this response to vaccine.
Time-to-Next Treatment Benefit in MCL: In addition to the overall
survival benefit observed, there was also a highly statistically
significant association between the BiovaxID-induced T-cell response and
time-to-next-treatment benefit with a nearly a 10-fold improvement for
those patients that developed this specific BiovaxID-induced T-cell
response versus those who did not (51.9 months versus 5.5 months from
the time of first progression).